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Trulicity ® (dulaglutid) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
In phase 3 studies, treatment with dulaglutide 1.5 mg was associated with sustained weight reduction from baseline over the duration of the studies including the longest study (AWARD-5, 104-week final endpoint) (Table 1).1-10
The LSM change in BW from baseline to primary endpoint ranged from
-0.87 kg (AWARD-4) to -3.10 kg (AWARD-10) with dulaglutide 1.5 mg treatment, and
+0.20 kg (AWARD-1 , AWARD-4) to -2.60 kg (AWARD-5, AWARD-10) with dulaglutide 0.75 mg treatment.1-10
In the AWARD-11 study, using the treatment-regimen estimand, the LSM changes in BW from baseline to primary endpoint at 36 weeks were
- 3.0 kg with dulaglutide 1.5 mg treatment
- 3.8 kg with dulaglutide 3 mg treatment, and
- 4.6 kg with dulaglutide 4.5 mg treatment.11
Table 1. Changes in Body Weight From Baseline to Primary Endpoint in AWARD Studies1-11ab
Primary Endpoint |
DULA 1.5 mgc |
DULA 0.75 mgc |
Comparatorc |
P Value |
AWARD-31 – Comparator – MET |
||||
26 weeks |
-2.29 |
-1.36 |
-2.22 |
p<.05
DULA 1.5 mg vs DULA 0.75 mg |
AWARD-52– Comparator – SITA and PBOa |
||||
52 weeks |
-3.03 |
-2.60 |
-1.53 |
p<.001 both DULA vs SITA |
AWARD-63 – Comparator – LIRA |
||||
26 weeks |
-2.90 |
NA |
-3.61 |
p=.011 DULA 1.5 mg vs LIRA |
AWARD-84 – Comparator – PBO |
||||
24 weeks |
-0.91 |
NA |
-0.24 |
p=.120 DULA 1.5 mg vs PBO |
AWARD-15 – Comparator – EXE BID and PBOa |
||||
26 weeks |
-1.30 |
0.20 |
-1.07 |
p<.001
both DULA vs EXE |
AWARD-106 – Comparator – PBO |
||||
24 weeks |
-3.10 |
-2.60 |
-2.10 |
p=.028
DULA 1.5 mg vs PBO |
AWARD-27– Comparator – GLA |
||||
52 weeks |
-1.87 |
-1.33 |
1.44 |
p<.001 both DULA vs GLA |
AWARD-98 – Comparator – PBO |
||||
28 weeks |
-1.91 |
NA |
0.50 |
p<.001 DULA 1.5 mg vs PBO |
AWARD-49 – Comparator – GLA |
||||
26 weeks |
-0.87 |
0.18 |
2.33 |
p<.001 both DULA vs GLA |
AWARD-710 – Comparator – GLA |
||||
26 weeks |
-2.81 |
-2.02 |
1.11 |
p<.0001 both DULA vs GLA |
AWARD-1111– Comparator – DULA |
||||
|
DULA 4.5 mg |
DULA 3 mg |
DULA 1.5 mgd |
P Value |
36 weekse |
-4.6 |
-3.8f |
-3.0 |
p<.001
DULA 4.5 mg vs DULA 1.5 mg |
36 weeksg |
-4.7 |
-4.0 |
-3.1 |
p<.001
DULA 4.5 mg vs DULA 1.5 mg |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; BID = twice daily; DULA = dulaglutide; EXE = exenatide; GLA = insulin glargine; LIRA = liraglutide; LSM = least squares mean; MET = metformin; PBO = placebo; SITA = sitagliptin.
a LSM Changes in body weight from baseline to primary time point are not shown for placebo.
b Data presented as LSM kg
c Unless otherwise noted.
d Active control group.
e Treatment regimen estimand.
f Nominal p-value, DULA 3 mg did not meet superiority criteria under graphical testing procedure.
1. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37(8):2168-2176. https://doi.org/10.2337/dc13-2759
2. Nauck M, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37(8):2149-2158. http://dx.doi.org/10.2337/dc13-2761
3. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. https://doi.org/10.1016/S0140-6736(14)60976-4
4. Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634
5. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37(8):2159-2167. https://doi.org/10.2337/dc13-2760
6. Ludvik B, Frías JP, Tinahones FJ, et al. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018;6(5):370-381. https://doi.org/10.1016/S2213-8587(18)30023-8
7. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38(12):2241-2249. https://doi.org/10.2337/dc14-1625
8. Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017;19(7):1024-1031. http://dx.doi.org/10.1111/dom.12937
9. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385(9982):2057-2066. https://doi.org/10.1016/S0140-6736(15)60936-9
10. Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018;6(8):605-617. https://doi.org/10.1016/S2213-8587(18)30104-9
11. Frias JP, Bonora E, Ruiz LM, et al. 357-OR: Efficacy and safety of dulaglutide 3mg and 4.5mg vs. dulaglutide 1.5mg: 52-week results from AWARD-11 [abstract]. Diabetes 2020 Jun; 69(Supplement 1): https://doi.org/10.2337/db20-357-OR
Glossary
AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes
BW = body weight
LSM = least squares mean
Datum fӧr senaste ӧversyn 2020 M08 18